Advanced/metastatic ovarian cancer resistant or refractory to platinum. MedDRA version: 6.1 Level: PT Classification code 10033128
Conditions
Interventions
Product Name: Brostallicin
Product Code: PNU-166196A
Pharmaceutical Form: Powder for infusion*
CAS Number: 203258-60-0
Current Sponsor code: PNU-166196A
Concentration unit: mg milligram(s)
Concentrati
Sponsors
NERVIANO MEDICAL SCIENCES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically proven diagnosis of advanced/metastatic epithelian ovarian cancer 2.Progressive disease after at least one prior platinum based regimen 3.Age / 18 4.Eastern Cooperative Oncology Group ECOG performance status PS of 0 or 1 5.Life expectancy of / 3 months at study entry i.e. from informed consent signature date 6.At least one measurable lesion according to RECIST criteria 7.All acute toxic effects excluding alopecia of any prior therapy must have resolved to CTCAE Version 3.0 Grade / 1 8.Required initial laboratory data to be eligible for study entry are Absolute neutrophil count ANC / 1,500/mm3 / Grade 1 , Platelets PLT / 100,000/mm3, Hemoglobin / 10.0 g/dL / Grade 1 , Total serum bilirubin / 1.5 x ULN / Grade 1 , Liver transaminases AST/ALT / 2.5 x ULN; / Grade 1 ; in case of liver metastasis / 5 x ULN , Alkaline Phosphatase ALP / 2.5 x ULN / Grade 1 ; in case of liver metastasis / 5 x ULN , Serum Albumin / 3.0 g/dL / Grade 1 , Serum creatinine / 1.25 x ULN / 133 mcmol/L and/or creatinine clearance / 60 mL/min 9.Wash out period of at least 4 weeks from surgery, from radiotherapy or from previous chemotherapy 10.Negative serum pregnancy test for females of childbearing potential / 7 days before starting treatment 11.Signed written informed consent prior to beginning protocol specific procedures 12.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients who received more than 2 prior chemotherapy lines of treatment for advanced/metastatic ovarian cancer 2.Second malignancies. Patients with prior history of other malignancies must have been disease free for / 5 years. Previous histories of basal cell carcinoma of the skin or in situ carcinoma of the cervix are accepted 3.Patients with clinically significant cardiac disease or myocardial infarction within the last 6 months before study entry 4.Known brain or leptomeningeal disease CT-scan or MRI of the brain required only in case of clinical suspicion of central nervous system metastases 5.Active uncontrolled infection including known positive human immunodeficiency virus HIV 6.Pregnancy or breast-feeding. Patients must agree to avoid becoming pregnant during the study and in the following 3 months after the end of the treatment, be surgically sterile or be postmenopausal. 7.Irradiation to / 25 of her bone marrow 8.Concomitant treatment with any other anti-cancer therapy and/or investigational agent 9.Patients who have participated in any investigational drug study within 4 weeks preceding treatment start 10.Medical or psychological condition that would not permit the patient to complete the trial or understand and sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antitumor activity of brostallicin as second/third line chemotherapy in adult patients with advanced/ metastatic ovarian cancer resistant/refractory to platinum based therapy.;Secondary Objective: To determine the safety profile of brostallicin in these patients. To assess the time-related efficacy endpoints. To monitor response to therapy by tumor marker evaluation.;Primary end point(s): Objective tumor response rate RR the RECIST criteria will be used to assess responses. | — |
Countries
Italy
Outcome results
None listed